Case 1:13-cv-01679-GMS Document 1 Filed 10/09/13 Page 1 of 11 PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`CUBIST PHARMACEUTICALS, INC.,
`
`Plaintiff,
`
`v.
`
`STRIDES, INC. and A GILA SPECIAL TIES
`PRIVATE LIMITED,
`
`Defendant.
`
`)
`)
`)
`)
`) C.A. No . - - - - - - - (cid:173)
`)
`)
`)
`)
`)
`
`COMPLAINT
`
`Plaintiff Cubist Pharmaceuticals, Inc., by its attorneys, alleges as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement under the patent laws of the United
`
`States, Title 35, United States Code, that arises out of the filing by Defendants Strides, Inc.
`
`("Strides") and Agila Specialties Private Limited ("Agila") (collectively, "Defendants") of
`
`Abbreviated New Drug Application ("ANDA") No. 205037 with the U.S. Food and Drug
`
`Administration ("FDA") seeking approval to manufacture and sell a generic version of
`
`CUBICIN® prior to the expiration of U.S. Patent Nos. 6,468,967; 6,852,689; 8,058,238; and
`
`8,129,342.
`
`PARTIES
`
`2.
`
`Plaintiff Cubist Pharmaceuticals, Inc. ("Cubist") is a corporation organized and
`
`existing under the laws of the State of Delaware, with its principal place of business at 65
`
`Hayden A venue, Lexington, Massachusetts.
`
`3.
`
`Upon information and belief, defendant Strides is a New Jersey corporation, with
`
`its principal place ofbusiness at 201 South Main Street, Suite #3, Lambertville, NJ 08530.
`
`PETITIONER - EXHIBIT 1024
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`CUBIST PHARMACEUTICALS, INC.,
`
`Plaintiff,
`
`v.
`
`STRIDES, INC. and A GILA SPECIAL TIES
`PRIVATE LIMITED,
`
`Defendant.
`
`)
`)
`)
`)
`) C.A. No . - - - - - - - (cid:173)
`)
`)
`)
`)
`)
`
`COMPLAINT
`
`Plaintiff Cubist Pharmaceuticals, Inc., by its attorneys, alleges as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement under the patent laws of the United
`
`States, Title 35, United States Code, that arises out of the filing by Defendants Strides, Inc.
`
`("Strides") and Agila Specialties Private Limited ("Agila") (collectively, "Defendants") of
`
`Abbreviated New Drug Application ("ANDA") No. 205037 with the U.S. Food and Drug
`
`Administration ("FDA") seeking approval to manufacture and sell a generic version of
`
`CUBICIN® prior to the expiration of U.S. Patent Nos. 6,468,967; 6,852,689; 8,058,238; and
`
`8,129,342.
`
`PARTIES
`
`2.
`
`Plaintiff Cubist Pharmaceuticals, Inc. ("Cubist") is a corporation organized and
`
`existing under the laws of the State of Delaware, with its principal place of business at 65
`
`Hayden A venue, Lexington, Massachusetts.
`
`3.
`
`Upon information and belief, defendant Strides is a New Jersey corporation, with
`
`its principal place ofbusiness at 201 South Main Street, Suite #3, Lambertville, NJ 08530.
`
`PETITIONER - EXHIBIT 1024
`
`
`
`Case 1:13-cv-01679-GMS Document 1 Filed 10/09/13 Page 2 of 11 PageID #: 2
`
`4.
`
`Upon information and belief, defendant Agila is a corporation organized under the
`
`laws oflndia, with its principal place ofbusiness at Strides House, Bilekahalli, Bannerghatta
`
`Road, Bangalore 560076 India.
`
`5.
`
`Upon information and belief, defendant Strides is the U.S. agent for defendant
`
`Agila. Upon information and belief, defendants Strides and Agila are wholly owned subsidiaries
`
`of Strides Arcolab Ltd. that act in concert with respect to collaborating in the development,
`
`manufacturing, marketing, and sale of generic copies of branded pharmaceutical products,
`
`including daptomycin for injection. On information and belief, defendants Strides and Agila
`
`import, distribute, manufacture, market, and/or sell generic versions of branded drugs in, and
`
`regularly conduct business throughout, the United States, including in Delaware.
`
`JURISDICTION AND VENUE
`
`6.
`
`This action arises under the patent laws of the United States of America and this
`
`Court has jurisdiction over the subject matter of this action pursuant to 28 U.S. C. §§ 1331,
`
`1338(a), 2201, and 2202.
`
`7.
`
`8.
`
`Venue is proper in this district pursuant to 28 U.S. C. §§ 1391 and 1400(b).
`
`Defendants are subject to personal jurisdiction in Delaware because of their
`
`continuous and systematic contacts with Delaware. Upon information and belief, Defendants
`
`directly or indirectly purposefully offer to sell, sell, market, distribute, and/or manufacture
`
`goods, including generic pharmaceutical products, for sale in the United States and Delaware;
`
`derive substantial revenue from things used or consumed in Delaware; regularly do business and
`
`solicit business in Delaware; and have admitted, consented to, and/or not objected to jurisdiction
`
`in this Court, including, for example, in Aventis Pharma S.A. et al. v. Strides, Inc. eta!., C.A. No.
`
`11-1121-GMS (D. Del.) and Senju Pharmaceutical Co., Ltd eta/. v. Strides, Inc. et al., C.A. No.
`
`13-851-SLR (D. Del.).
`
`-2-
`
`
`
`Case 1:13-cv-01679-GMS Document 1 Filed 10/09/13 Page 3 of 11 PageID #: 3
`
`9.
`
`Alternatively, Agila is subject to personal jurisdiction in Delaware pursuant to
`
`Fed. R. Civ. P. 4(k)(2). Agila has contacts with the United States through, among other things,
`
`its having filed an ANDA with the FDA through its agent corporation, Strides, and its
`
`importation, distribution, manufacture, marketing, and/or sale of generic versions of branded
`
`drugs in the United States.
`
`BACKGROUND
`
`I 0.
`
`CUBICIN® (daptomycin for injection) is an intravenous bactericidal antibiotic
`
`approved by the FDA for the treatment of complicated skin and skin structure infections caused
`
`by certain Gram-positive microorganisms, such as Staphylococcus aureus, including methicillin(cid:173)
`
`resistant strains, also known as MRSA. CUBICIN® is also approved for the treatment of
`
`S. aureus bloodstream infections (bacteremia), including right-sided infective endocarditis
`
`caused by MRSA.
`
`11.
`
`Cubist sells CUBICIN® in the United States pursuant to a New Drug Application
`
`that has been approved by the FDA.
`
`12.
`
`United States Patent No. 6,468,967 (''the '967 patent"), entitled "Methods for
`
`Administration of Antibiotics" (Exhibit A hereto), was duly and legally issued on October 22,
`
`2002. The '967 patent, which is owned by Cubist, will expire on September 24,2019.
`
`13.
`
`United States Patent No. 6,852,689 ("the '689 patent"), entitled .. Methods for
`
`Administration of Antibiotics" (Exhibit B hereto), was duly and legally issued on February 8,
`
`2005. The '689 patent, which is owned by Cubist, will expire on September 24, 2019.
`
`14.
`
`United States Patent No. 8,058,238 ("the '238 patent"), entitled "High Purity
`
`Lipopeptides" (Exhibit C hereto), was duly and legally issued on November 15, 2011. The '238
`
`patent, which is owned by Cubist, will expire on November 28, 2020.
`
`-3-
`
`
`
`Case 1:13-cv-01679-GMS Document 1 Filed 10/09/13 Page 4 of 11 PageID #: 4
`
`15.
`
`United States Patent No. 8,129,342 ("the '342 patenf'), entitled "High Purity
`
`Lipopeptides" (Exhibit D hereto), was duly and legally issued on March 6, 2012. The '342
`
`patent, which is owned by Cubist, will expire Oil November 28, 2020.
`
`16.
`
`CUBICJN®, or its use, is covered by one or more claims of the '967, '689, '238,
`
`and '342 patents, which have been listed in connection with CUBICIN® in the FDA's
`
`publication, Approved Drug Products with Therapeutic Equivalence Evaluations, referred to as
`
`the "Orange Book."
`
`17.
`
`By letter dated August 26, 2013 (the "Notice Letter"), Defendants notified Cubist
`
`that they had submitted to the FDA ANDA No. 205037 for Daptomycin for Injection,
`
`500mglvial, a generic version of CUBICIN® ("Strides's ANDA Product").
`
`18.
`
`In the Notice Letter, Defendants stated that their ANDA included certifications
`
`pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) with respect to the '967, '689, '238, and '342
`
`patents and alleged that the '967, '689, '238, and '342 patents are invalid, unenforceable, ar1d/or
`
`will not be infringed by the commercial mar1ufacture, use, offer for sale, or sale of Strides's
`
`ANDA Product.
`
`19.
`
`This action is being commenced before the expiration of forty-five days from the
`
`date of the receipt of the Notice Letter.
`
`COUNT I
`
`INFRINGEMENT OF U.S. PATENT NO. 6.468,967
`
`20.
`
`Plaintiff incorporates each of the proceeding paragraphs 1 - 19 as if fully set forth
`
`herein.
`
`patent.
`
`21.
`
`The use of Strides's ANDA Product is covered by one or more claims of the '967
`
`-4-
`
`
`
`Case 1:13-cv-01679-GMS Document 1 Filed 10/09/13 Page 5 of 11 PageID #: 5
`
`22.
`
`Defendants had knowledge of the '967 patent when they submitted their ANDA
`
`to the FDA.
`
`23.
`
`Defendants' submission of ANDA No. 205037 for the purpose of obtaining
`
`approval to engage in the commercial manufacture, use, offer for sale, and/ or sale of Strides's
`
`ANDA Product before the expiration of the· '967 patent is an act of infringement of the '967
`
`patent.
`
`24.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of
`
`Strides's ANDA Product would infringe one or more claims of the '967 patent.
`
`25. Upon information and belief, use of Strides's ANDA Product in accordance with
`
`and as directed by Defendants' proposed labeling for that product would infringe one or more
`
`claims of the '967 patent.
`
`26.
`
`Upon information and belief, Defendants intend to engage irt the manufacture,
`
`use, offer for sale, sale, and/or importation of Strides's ANDA Product with its proposed labeling
`
`immediately and imminently upon approval of ANDA No. 205037.
`
`27.
`
`Upon information and belief, Defendants will actively induce infringement of the
`
`'967 patent when their ANDA is approved, and plan and intend to, and will do so, immediately
`
`and imminently upon approval.
`
`28.
`
`Upon information and belief, Defendants know that Strides's ANDA Product and
`
`its proposed labeling are especially made or adapted for use irt infringing the '967 patent, and
`
`that Strides's ANDA Product and its proposed labeling are not suitable for substantial
`
`noninfringing use. Upon information and belief, Defendants plan and intend to, and will,
`
`contribute to the infringement of the '967 patent immediately and imminently upon approval of
`
`ANDA No. 205037.
`
`-5-
`
`
`
`Case 1:13-cv-01679-GMS Document 1 Filed 10/09/13 Page 6 of 11 PageID #: 6
`
`29.
`
`The foregoing actions by Defendants constitute and/or would constitute
`
`infringement of the '967 patent, active inducement of infringement of the '967 patent, and/or
`
`contribution to the infringement by others of the '967 patent.
`
`30.
`
`Upon information and belief, Defendants acted without a reasonable basis for
`
`believing that they would not be liable for infringing the '967 patent, actively inducing
`
`infringement ofthe '967 patent, and/or contributing to the infringement by others of the '967
`
`patent.
`
`31.
`
`Unless Defendants are enjoined from infringing the '967 patent, actively inducing
`
`infringement of the '967 patent, and/or contributing to the infringement by others of the '967
`
`patent, Cubist will suffer irreparable injury; Cubist has no adequate remedy at law.
`
`COUNT II
`
`INFRINGEMENT OF U.S. PATENT NO. 6,852,689
`
`32.
`
`Plaintiff incorporates each of the proceeding paragraphs 1 - 31 as if fully set forth
`
`herein.
`
`patent.
`
`33.
`
`The use ofStrides;s ANDA Product is covered by one or more claims of the '689
`
`34.
`
`Defendants had knowledge of the '689 patent when they submitted their ANDA
`
`to the FDA.
`
`35.
`
`Defendants' submission of ANDA No. 205037 for the purpose of obtaining
`
`approval to engage in the commercial manufacture, use, offer for sale, and/or sale of Strides's
`
`ANDA Product before the expiration of the '689 patent is an act of infringement of the '689
`
`patent.
`
`-6-
`
`
`
`Case 1:13-cv-01679-GMS Document 1 Filed 10/09/13 Page 7 of 11 PageID #: 7
`
`36.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of
`
`Strides's ANDA Product would infringe one or more claims of the '689 patent.
`
`37.
`
`Upon information and belief, use of Strides's ANDA Product in accordance with
`
`and as directed by Defendants' proposed labeling for that product would infringe one or more
`
`claims of the '689 patent.
`
`38.
`
`Upon information and belief, Defendants intend to engage in the manufacture,
`
`use, offer for sale, sale, and/or importation of Strides's ANDA Product with its proposed labeling
`
`immediately and imminently upon approval of ANDA No. 205037.
`
`39.
`
`Upon information and belief, Defendants will actively induce infringement of the
`
`'689 patent when their ANDA is approved, and plan and intend to, and will do so, immediately
`
`and imminently upon approval.
`
`40.
`
`Upon information and belief, Defendants know that Strides's ANDA Product and
`
`its proposed labeling are especially made or adapted for use in infringing the '689 patent, and
`
`that Strides's ANDA Product and its proposed labeling are not suitable for substantial
`
`noninfringing use. Upon information and belief, Defendants plan and intend to, and will,
`
`contribute to the infringement of the '689 patent inunediately and imminently upon approval of
`
`ANDA No. 205037.
`
`41.
`
`The foregoing actions by Defendants constitute and/or would constitute
`
`infringement of the '689 patent, active inducement of infringement of the '689 patent, and/or
`
`contribution to the infringement by others of the '689 patent.
`
`42.
`
`Upon information and belief, Defendants acted without a reasonable basis for
`
`believing that they would not be liable for infringing the '689 patent, actively inducing
`
`-7-
`
`
`
`Case 1:13-cv-01679-GMS Document 1 Filed 10/09/13 Page 8 of 11 PageID #: 8
`
`infringement of the '689 patent, and/or contributing to the infringement by others of the '689
`
`patent.
`
`43.
`
`Unless Defendants are enjoined from infringing the '689 patent, actively inducing
`
`infringement of the '689 patent, and/or contributing to the infringement by others of the '689
`
`patent, Cubist will suffer irreparable injury. Cubist has no adequate remedy at law.
`
`COUNT III
`
`INFRINGEMENT OF U.S. PATENT NO. 8,058,238
`
`44.
`
`Plaintiff incorporates each of the proceeding paragraphs 1 - 43 as if fully set forth
`
`herein.
`
`45.
`
`46.
`
`Strides's ANDA Product is covered by one or more claims of the '238 patent.
`
`Defendants' submission of ANDA No. 205037 for the purpose of the obtaining
`
`approval to engage in the commercial manufacture, use, offer for sale, and/or sale of Strides's
`
`ANDA Product before the expiration of the '238 patent is an act of infringement of the '238
`
`patent.
`
`47.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of
`
`Strides's ANDA Product would infringe one or more claims of the '238 patent.
`
`48.
`
`Upon information and belief, Defendants intend to engage in the manufacture,
`
`use, offer for sale, sale, and/or importation of Strides's ANDA Product immediately and
`
`imminently upon approval of ANDA No. 205037.
`
`49.
`
`The foregoing actions by Defendants constitute and/or would constitute
`
`infringement of the '23 8 patent.
`
`50.
`
`Unless Defendants are enjoined from infringing the '238 patent, Cubist will suffer
`
`irreparable injury. Cubist has no adequate remedy at law.
`
`-8-
`
`
`
`Case 1:13-cv-01679-GMS Document 1 Filed 10/09/13 Page 9 of 11 PageID #: 9
`
`COUNT IV
`
`INFRINGEMENT OF U.S. PATENT NO. 8,129,342
`
`51.
`
`Plaintiff incorporates each of the proceeding paragraphs 1-50 as if fully set forth
`
`herein.
`
`52.
`
`53.
`
`Strides's ANDA Product is covered by one or more claims of the '342 patent.
`
`Defendants' submission of ANDA No. 205037 for the purpose ofthe obtaining
`
`approval to engage in the commercial manufacture, use, offer for sale, and/or sale of Strides's
`
`ANDA Product before the expiration of the '342 patent is an act of infringement of the '342
`
`patent.
`
`54.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of
`
`Strides's ANDA Product would infringe one or more claims of the '342 patent.
`
`55. Upon information and belief, Defendants intend to engage in the manufacture,
`
`use, offer for sale, sale, and/or importation of Strides's ANDA Product immediately and
`
`imminently upon approval of ANDA No. 205037.
`
`56.
`
`The foregoing actions by Defendants constitute and/or would constitute
`
`infringement of the '342 patent.
`
`57.
`
`Unless Defendants are enjoined from infringing the '342 patent, Cubist will suffer
`
`irreparable injury. Cubist has no adequate remedy at law.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiff prays that this Court grant the following relief:
`
`(a)
`
`A judgment that Defendants' submission of ANDA No. 205037 was an act of
`
`infringement of the '967, '689, '238, and '342 patents, artd that Defendants' manufacture, use,
`
`offer to sell, sale, or importation of Strides's ANDA Product prior to the expiration of the '967,
`
`-9-
`
`
`
`Case 1:13-cv-01679-GMS Document 1 Filed 10/09/13 Page 10 of 11 PageID #: 10
`
`'689, '238, and '342 patents, will infringe, actively induce infringement, and/or contribute to the
`
`infringement of the '967, '689, '238, and '342 patents;
`
`(b) An Order pursuant to 35 U.S.C. § 27l(e)(4)(A) providing that the effective date of
`
`any FDA approval of Strides's ANDA No. 205037, or any product or compound that infringes
`
`the '967, '689, '238, and '342 patents, shall not be earlier than the expiration of the '967, '689,
`
`'238 and '342 patents;
`
`(c)
`
`An Order permanently enjoining Defendants, and their affiliates and subsidiaries,
`
`and each of their officers, agents, servants and employees, from making, using, offering to sell,
`
`selling, marketing, distributing, or importing Strides's ANDA Product, or any product or
`
`compound that infringes the '967, '689, '238, and '342 patents, or inducing or contributing to the
`
`infringement of the '967, '689, '238, and '342 patents until after the expiration of the '967, '689,
`
`'238, and '342 patents;
`
`(d)
`
`A declaration that this is an exceptional case and an award of attorneys' fees to
`
`plaintiff pursuant to 35 U.S.C. § 285;
`
`(e)
`
`(f)
`
`Plaintiff's reasonable costs of suit incurred; and
`
`Such further and other relief as this Court deems proper and just.
`
`-10-
`
`
`
`Case 1:13-cv-01679-GMS Document 1 Filed 10/09/13 Page 11 of 11 PageID #: 11
`
`MORRIS. NICHOLS, ARSHT & TUNNELL LLP
`
`~~{L-~
`
`~B. Blumenfeld(#1014)
`Maryellen Noreika (#3208)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`mfioreika@mnat.com
`
`Attorneys for Plaintiff
`Cubist Pharmaceuticals, Inc.
`
`OF COUNSEL
`
`William F. Lee
`Lisa J. Pirozzolo
`Emily Whelan
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`60 State Street
`Boston, MA 021 09
`(617) 526-6000
`
`October 9, 2013
`7637761.1
`
`-11-
`
`
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